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NCT06143605 Clinical Trial

Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:
Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors Based on the Pathological Evaluation Following Initial Endoscopic Resection: A Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06143605
Other study ID # GIH-SYip33
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2013
Est. completion date September 30, 2023

Study information
Verified date November 2023
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.

Recruitment information / eligibility
Status Completed
Enrollment 527
Est. completion date September 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - within the age range of 18 to 65 years, diagnosed with rectal neuroendocrine tumors. Furthermore, patients were required to have a palpable tumor as determined by digital rectal examination or accessible through proctoscopy, with the distal border situated within 12 cm from the anal verge. Exclusion Criteria: - (1) muscularis propria invasion or NET grading = 3, (2)regional LN or distant organs metastasis at the time of diagnosis, (3) incomplete follow-up information, (4) the patient had multiple primary tumors, (5) patients with surgical excision or inappropriate methods such as forceps removal, and (6) the patient had a history of malignant tumors.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• salvage treatment
salvage radical surgery or endoscopic resection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yanhong Deng

Outcome
Type Measure Description Time frame Safety issue
Primary DFS disease free survival 5 year
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